search
Back to results

Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence (Ure-Na)

Primary Purpose

Kidney Stone

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ure-Na
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Stone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 60 years of age
  • High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.)
  • Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months)

Exclusion Criteria:

  • Patient does not meet 1 of the 3 inclusion criteria
  • Pregnancy or breastfeeding
  • Lack of understanding about the protocol and effects of Ure-Na
  • Expected inability to adequately increase fluid intake on Ure-Na

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label

Arm Description

The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month

Outcomes

Primary Outcome Measures

Change From Baseline in urine output at 1 week and 1 Month
variation in 24-hour diuresis and urine biochemistry

Secondary Outcome Measures

Full Information

First Posted
November 17, 2020
Last Updated
November 22, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT04727606
Brief Title
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Acronym
Ure-Na
Official Title
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
We never got Health Canada approval
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence. The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label
Arm Type
Experimental
Arm Description
The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month
Intervention Type
Drug
Intervention Name(s)
Ure-Na
Intervention Description
Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) Treatment will continue for approximately 1 month.
Primary Outcome Measure Information:
Title
Change From Baseline in urine output at 1 week and 1 Month
Description
variation in 24-hour diuresis and urine biochemistry
Time Frame
1 week and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 60 years of age High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.) Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months) Exclusion Criteria: Patient does not meet 1 of the 3 inclusion criteria Pregnancy or breastfeeding Lack of understanding about the protocol and effects of Ure-Na Expected inability to adequately increase fluid intake on Ure-Na
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28096919
Citation
Dion M, Ankawi G, Chew B, Paterson R, Sultan N, Hoddinott P, Razvi H. CUA guideline on the evaluation and medical management of the kidney stone patient - 2016 update. Can Urol Assoc J. 2016 Nov-Dec;10(11-12):E347-E358. doi: 10.5489/cuaj.4218. Epub 2016 Nov 10. No abstract available.
Results Reference
background
PubMed Identifier
8583588
Citation
Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43.
Results Reference
background
PubMed Identifier
22403276
Citation
Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012 May;7(5):742-7. doi: 10.2215/CJN.06990711. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
18337482
Citation
Berl T. Impact of solute intake on urine flow and water excretion. J Am Soc Nephrol. 2008 Jun;19(6):1076-8. doi: 10.1681/ASN.2007091042. Epub 2008 Mar 12.
Results Reference
background
PubMed Identifier
7386514
Citation
Decaux G, Brimioulle S, Genette F, Mockel J. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by urea. Am J Med. 1980 Jul;69(1):99-106. doi: 10.1016/0002-9343(80)90506-9.
Results Reference
background
PubMed Identifier
3336285
Citation
Verbalis JG, Baldwin EF, Neish PN, Robinson AG. Effect of protein intake and urea on sodium excretion during inappropriate antidiuresis in rats. Metabolism. 1988 Jan;37(1):46-54. doi: 10.1016/0026-0495(88)90028-5.
Results Reference
background
PubMed Identifier
22396364
Citation
Nayan M, Elkoushy MA, Andonian S. Variations between two 24-hour urine collections in patients presenting to a tertiary stone clinic. Can Urol Assoc J. 2012 Feb;6(1):30-3. doi: 10.5489/cuaj.11131.
Results Reference
background

Learn more about this trial

Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

We'll reach out to this number within 24 hrs